Jin Beixin (firsekibart) / GeneScience - LARVOL DELTA

Efficacy and Safety of Firsekibart in Patients with Acute Gouty Arthritis with eGFR Less Than 60 mL/min per 1.73 m2: Post Hoc Analysis of 24-Week Data (KIDNEY WEEK 2025) - P3 | "Background About 70% gout patients have chronic kidney disease (CKD) stage ≥3 (estimated glomerular filtration rate (eGFR)<60ml/min/1.73m 2 ),limiting treatment options like colchicine or NSAIDs due to renal toxicity concerns.Firsekibart,previously known as Genakumab,is a novel IgG4/λ anti-IL-1β monoclonal antibody.It is not excreted via kidney,making it a significant option for acute gout arthritis(GA) with CKD.Here,we report the clinical results of Firsekibart vs compound betamethasone(CB) in a subgroup of GA patients with eGFR<60. Treatment emergent and treatment-related adverse events were 10 (47.6%) and 7 (33.3%) in Firsekibart group,versus 11 (52.4%) and 6 (28.6%) in CB group.No serious adverse events were reported in Firsekibart group.Neitiher Firsekibart nor CB showed significant damage to kidney function. Conclusion Compared with CB,Firsekibart showed a comparable effect in pain relief and offering significant better prevention of new flares in GA..."

Clinical • Retrospective data • Chronic Kidney Disease • Gout • Immunology • Inflammatory Arthritis • Nephrology • Renal Disease • Rheumatology • IL1B

Firsekibart as a Prophylactic Treatment for Acute Gout Flare in Participants Initiating Urate-Lowering Therapy: A Phase 2, Randomized, Open-Label, Multicenter, Active-Controlled Trial. (PubMed, ACR Open Rheumatol) - "Firsekibart provided superior prophylaxis against acute gout flares compared with colchicine in patients initiating ULT, with a favorable tolerability profile, supporting its potential as a treatment option for patients with gout initiating ULT."

Journal • P2 data • Gout • Inflammatory Arthritis • Rheumatology

Efficacy and Safety of Firsekibart versus Anakinra in Adult-Onset Still's Disease (ChiCTR) - P4 | N=20 | Not yet recruiting | Sponsor: Ruijin Hospital, Shanghai JiaoTong University School of Medicine; Ruijin Hospital, Shanghai JiaoTong University School of Medicine, Shanghai

New P4 trial • Immunology

Efficacy and Safety of Firsekibart in Acute Gouty Arthritis Patients with Limited Treatment Options: A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Phase III Trial (ACR Convergence 2025) - P3 | "Patients aged 18–75 years with GA, contraindicated of, intolerance of, or unresponsiveness to NSAIDs and/or colchicine, with ≥2 episodes during the last 12 months were screened for eligibility.Patients were randomized 1:1 to receive a single subcutaneous dose of Firsekibart (200 mg) or an intramuscular dose of CB 7 mg.The co-primary endpoints were change in pain intensity from baseline to 72 hours in the most affected joint measured on VAS (0–100 mm) and the time to first new episode over 12 weeks. Firsekibart is effective and well-tolerated for acute gout flares in patients with limited treatment options, demonstrating rapid pain relief and significant superiority in preventing flare compared with CB."

Clinical • P3 data • Dyslipidemia • Gout • Immunology • Inflammatory Arthritis • Metabolic Disorders • Rheumatology • IL1B

Efficacy and Safety of Firsekibart in Acute Gouty Arthritis Patients with eGFR < 60ml/min/1.73m2:A Post-Hoc Analysis of 24-Week Data (ACR Convergence 2025) - P3 | "Background/Purpose: Approximately 70% of adults with gout have CKD (Chronic Kidney Disease) ≥stage 3 (i.e estimated glomerular filtration rate (eGFR) < 60ml/min/1.73m2), significantly restricts treatment options such as colchicine or NSAIDs due to the potential renal toxicity. Compared with a potent long-acting corticosteroid (Compound betamethasone), Firsekibart showed a comparable effect in pain relief and offering significantly better prevention of new flares in GA patients with eGFR < 60ml/min/1.73m2. The safety profile in this sub population was consistent with that of the overall study population."

Clinical • Retrospective data • Chronic Kidney Disease • Gout • Immunology • Inflammatory Arthritis • Nephrology • Renal Disease • Rheumatology • IL1B

A Study of Firsekibart Versus Anakinra in Adult-Onset Still's Disease (clinicaltrials.gov) - P=N/A | N=20 | Not yet recruiting | Sponsor: Ruijin Hospital

New trial • Immunology

China approves…new drugs, including a global first-in-class medicine (Fierce Pharma) - "Outside of oncology, the NMPA cleared Changchun GeneScience Pharmaceutical’s firsekibart (formerly genakumab) for certain patients with acute gouty flares. To be eligible, patients must be unable to tolerate or respond to non-steroidal anti-inflammatory drugs and colchicine, and they must not be suitable to receive steroid hormones repeatedly."

China approval • Gout

Efficacy and safety of genakumab for first-line treatment of gout flare: A phase 2, multicenter, open-label, active controlled, randomized non-inferiority trial (EULAR 2025) - P2 | "Compared with daily oral etoricoxib, a single 200 mg subcutaneous injection of genakumab provides faster, more sustained relief of joint pain over 12 weeks, reduces recurrence risk, and is well tolerated as a first-line treatment for gout flares."

Clinical • Head-to-Head • P2 data • Dyslipidemia • Gout • Hypertriglyceridemia • Inflammatory Arthritis • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Rheumatology • IL1B

Genakumab reduces the risk of acute gout flares during initiation of urate-lowering therapy: A phase 2, randomized, open-label, multi-center, active-controlled clinical trial (EULAR 2025) - P2 | "ULT options included oral allopurinol 100 mg/day, febuxostat 40 mg/day, or benzbromarone 50 mg/day. Genakumab demonstrated efficacy as a prophylaxis against acute gout flares in adults with gout initiating ULT and was generally well-tolerated. A single dose of genakumab 100 mg or 200 mg reduced the average number of acute gout flares per patient and shortened flare duration over 12 weeks, with a safety profile similar to daily colchicine. Notably, in the genakumab 200 mg group, gout flares were not observed for the entire 12-week period, a finding that will be further investigated in larger sample populations."

Clinical • P2 data • Dyslipidemia • Gout • Hypertriglyceridemia • Inflammatory Arthritis • Pain • Rheumatology • IL1B

Efficacy and Safety of Genakumab in Active Systemic Juvenile Idiopathic Arthritis (sJIA): A Multicenter, Randomized, Open-Label Phase 2 Clinical Study (EULAR 2025) - P=N/A | "Genakumab demonstrated comparable efficacy to tocilizumab with a favorable safety profile in the treatment of active sJIA. Common TEAEs were consistent with the expected effects of IL-1 receptor antagonists. Both doses of genakumab showed promising therapeutic effects, with a lower incidence of TEAEs compared to tocilizumab."

Clinical • P2 data • Anemia • Dyslipidemia • Hematological Disorders • Idiopathic Arthritis • Immunology • Infectious Disease • Metabolic Disorders • Respiratory Diseases • Rheumatology • IL1B • IL6

Clinical Study of Multiple Dose Genakumab for Injection in Chinese Healthy Adults (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

Clinical Study of Genakumab for Injection in Patients With Acute Gout (clinicaltrials.gov) - P1/2 | N=121 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Gout • Inflammatory Arthritis • Rheumatology

A Bioequivalence Study of Two Different Dosage Form of Genakumab (clinicaltrials.gov) - P1 | N=178 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Rheumatology

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetic Profile of Genakumab Injection in Patients With Connective Tissue Disease-associated Interstitial Lung Disease (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Sclerosis

Gensci 048-202: A Study of the Efficacy of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering (GenSci048-202) (clinicaltrials.gov) - P2 | N=165 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | N=106 ➔ 165 | Trial completion date: May 2024 ➔ Jan 2024

Enrollment change • Trial completion date • Gout • Inflammatory Arthritis • Rheumatology

Efficacy and Safety of Genakumab versus Compound Betamethasone in Gout: The GUARD-1 Study (ACR Convergence 2024) - "In summary, in adults in whom NSAIDs and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response,Genakumab was demonstrated non-inferiority to Compound betamethasone in pain relief of gouty arthritis attacks, and superiority to Compound betamethasone within 12 weeks in delaying new flare which can be maintained until the end of the 24 weeks."

Clinical • Gout • Immunology • Inflammatory Arthritis • Pain • Rheumatology • IL1B

Safety & Efficacy of Genakumab in Patients With Frequent Flares (clinicaltrials.gov) - P3 | N=302 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Jul 2024 ➔ Apr 2024 | Trial primary completion date: Oct 2023 ➔ Apr 2024

Trial completion • Trial completion date • Trial primary completion date • Gout • Inflammatory Arthritis • Rheumatology • CRP

Gensci 048-202: Safety and Efficacy of Genakumab for Injection in Patients With Gout Initiating Urico-lowering Therapy (clinicaltrials.gov) - P2 | N=106 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Completed | Trial completion date: Feb 2024 ➔ May 2024

Trial completion • Trial completion date • Gout • Immunology • Inflammatory Arthritis • Rheumatology

Gensci 048-203: Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare (clinicaltrials.gov) - P2 | N=106 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • Gout • Inflammatory Arthritis • Rheumatology

A Bioequivalence Study of Two Different Dosage Form of Genakumab (clinicaltrials.gov) - P1 | N=178 | Active, not recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Rheumatology

To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis. (clinicaltrials.gov) - P=N/A | N=221 | Recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting | Phase classification: P2b ➔ PN/A | N=30 ➔ 221 | Trial completion date: Oct 2024 ➔ Jun 2028 | Trial primary completion date: Jul 2024 ➔ Mar 2028

Enrollment change • Enrollment open • Phase classification • Trial completion date • Trial primary completion date • Idiopathic Arthritis • Immunology • Rheumatology

A Bioequivalence Study of Two Different Dosage Form of Genakumab (clinicaltrials.gov) - P1 | N=178 | Recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New P1 trial • Immunology • Inflammatory Arthritis • Rheumatology

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetic Profile of Genakumab Injection in Patients With Connective Tissue Disease-associated Interstitial Lung Disease (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New P2 trial • Fibrosis • Immunology • Inflammatory Arthritis • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Sclerosis

Gensci 048-203: Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare (clinicaltrials.gov) - P2 | N=106 | Recruiting | Sponsor: GeneScience Pharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Gout • Inflammatory Arthritis • Rheumatology

Gensci 048-203: Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare (clinicaltrials.gov) - P2 | N=106 | Not yet recruiting | Sponsor: GeneScience Pharmaceuticals Co., Ltd.

New P2 trial • Gout • Inflammatory Arthritis • Rheumatology